Use of Vidangadi Loha as compared to Metformin in Prediabetes

A Randomized Controlled Parallel Two Arm Study to Evaluate the Efficacy of Vidangadi Loha as Compared to Metformin in The Management of Prameha w.s.r to Prediabetes

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037124

Enrollment

160

Registered

2021-10-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R739- Hyperglycemia, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed cases of hyperglycaemia with lakshanas of Prameha like Prabhut mootrata, Trishna, Kshudhadhikya, Dourbalya, Dantadinammaladhyatvam, Atinidra with Madhumeha Assessment Tool (As mentioned in case paper) Score more than 10 and patients those having Blood Sugar level fasting 100 to 125, Postprandial Blood sugar level more than 140 and less than 200 and HbA1C 5.7 to 6.4 % will be selected for the study.{According to Rashtriya Madhumeha Abhiyan , Ministry of Ayush, Government of India} According to American Diabetes Association Criteria.

Exclusion criteria

Exclusion criteria: i) Type 2 Diabetes Patients, Juvenile Diabetes, Pregnancy induced Diabetes Mellitus patients will be excluded from study. ii) Patients receiving insulin and those with increased blood sugar level and showing normal or poor control in glycosylated hemoglobin. iii) Patients Suffering from Diabetic Complications like Neuropathy, Retinopathy, Nephropathy, keto acidosis, Gangrene will be excluded from study. iv) Immune deficiency patient, chronic major illness will be also excluded from study.

Design outcomes

Primary

Measure	Time frame
1.To evaluate the efficacy of Vidgandi Loha in the management of Prediabetes based on serum levels of fasting and postprandial blood glucoseTimepoint: 90 days with Follow Up on 30th,60th and 90th day	—

Secondary

Measure	Time frame
1. To study the efficacy of Vidangadi loha in the management of Prediabetes based on serum levels of fasting and postprandial blood glucose. 2. To compare the effect of Vidangadi Loha with standard Metformin in the management of Prameha with special reference to Prediabetes. 3. To evaluate the efficacy of Vidangadi loha tablets in the management of Prediabetes compared with Metformin tablet based on Glycosylated hemoglobin, lipid profile and clinical symptoms. 4. To review the modern literature on Prediabetes in detail. Timepoint: 90 days with Follow Up on 30th,60th and 90th day	—

Measure

Time frame

1. To study the efficacy of Vidangadi loha in the management of Prediabetes based on serum levels of fasting and postprandial blood glucose. 2. To compare the effect of Vidangadi Loha with standard Metformin in the management of Prameha with special reference to Prediabetes. 3. To evaluate the efficacy of Vidangadi loha tablets in the management of Prediabetes compared with Metformin tablet based on Glycosylated hemoglobin, lipid profile and clinical symptoms. 4. To review the modern literature on Prediabetes in detail. Timepoint: 90 days with Follow Up on 30th,60th and 90th day

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Countries

India

Contacts

Public ContactDr Sonal Abhijeet Shah

D. Y. Patil Medical College, Hospital & Research Centre

gunvant.yeola@dpu.edu.in9028321955

Outcome results